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Last Updated: October 20, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079098


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NDA 079098 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Annora Pharma, Atlantide, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel Pharma, Nostrum Labs Inc, Osmotica Pharm, Sun Pharm, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Fosun Pharma, Heritage Pharms Inc, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in thirty-eight NDAs. It is available from fifty-nine suppliers. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.

The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
Summary for 079098
Tradename:VENLAFAXINE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:venlafaxine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079098
Suppliers and Packaging for NDA: 079098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098 ANDA AvKARE, Inc. 42291-892 42291-892-90 90 TABLET in 1 BOTTLE (42291-892-90)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098 ANDA AvKARE, Inc. 42291-893 42291-893-90 90 TABLET in 1 BOTTLE (42291-893-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:May 11, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 37.5MG BASE
Approval Date:May 11, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:May 11, 2010TE:ABRLD:No

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